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The device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on new borns, infants, children, young adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds.

The ANEROID SPHYGMOMANOMETER and ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE are manual blood pressure monitor used to measure blood presure.It consists of a cuff,a inflation bulb,a pressure gauge, an air valve and a stethoscope(optional).

Cuff: The cuff is made of a durable fabric and is wrapped around the upper arm of the patient. It inflates and deflates during the measurement process. The material of outside layer is nylon cloth.

Inflation Bulb: The inflation bulb is a rubber bulb that connects to the cuff and is used to manually inflate the cuff with air. The material is Neoprene or Silicon rubber or Nature latex or PVC.

Pressure Gauge: The pressure gauge is a circular dial with a needle that indicates the pressure within the cuff. It is calibrated in millimeters of mercury (mmHg) and shows the systolic and diastolic blood pressure readings. The material is Aluminum or ABS.

Air Valve: The valve is a control mechanism that allows for the release of air from the cuff once the measurement is complete.

Stethoscope: Although not a part of the device itself, a stethoscope is typically used in conjunction with an Aneroid Sphygmomanometer to listen for the blood flow sounds, known as Korotkoff sounds, in the brachial artery during the measurement. Three model are single head Stethoscope(Model: TY-S01),Dual Head Stethoscope(Model: TY-S05) and Spraque Rappaport Stethoscope(Model: TY-S04) individually.These stethoscopes are listed in FDA database.

The provided submission describes an Aneroid Sphygmomanometer. Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that the "Accuracy" of the device is ± 3 mmHg, which is also the performance reported. For "Biocompatibility" and "Safety & Performance", compliance with the specified ISO standards is the stated performance.

Note: The submission describes an aneroid sphygmomanometer, which is a mechanical device. The concept of an "AI device" with human-in-the-loop performance or standalone performance, sample sizes for test/training sets, adjudication methods, and expert qualifications for ground truth establishment, are not applicable to this type of device. The provided text is a 510(k) summary for a traditional medical device, not an AI/ML-powered device.

Therefore, the following points are answered with "Not Applicable" (N/A) due to the nature of the device.

2. Sample size used for the test set and the data provenance
N/A - This device is a mechanical blood pressure monitor, not an AI/ML-powered device that uses a "test set" in the context of data. The performance testing refers to compliance with a standard (ISO 81060-1), which involves testing the device itself, not an algorithm's performance on a dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A - See explanation above.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A - See explanation above.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
N/A - This is a mechanical device, not an AI-assisted one.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A - This is a mechanical device, not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
N/A - The ground truth for this device's accuracy would be established by direct comparison to a reference standard, as defined by ISO 81060-1, which likely involves a calibrated pressure standard.

8. The sample size for the training set
N/A - This is a mechanical device, not an AI/ML-powered device that requires a "training set."

9. How the ground truth for the training set was established
N/A - See explanation above.

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